Some advocacy groups are expressing their frustrations at the seemingly slow pace at which U.S. policymakers are moving on drug pricing reform, The Hill reports. Julie Allen, senior vice president of the District Policy Group at Drinker Biddle, tells The Hill their expectations for the remainder of […]
Industry, FDA: RWE Needs Standardized Definition in Clinical Trials
The Food and Drug Administration (FDA) and pharmaceutical industry agree real-world evidence (RWE) and real-world data (RWD) both need standardized definitions as their use in clinical trials grows, CenterWatch reports. The FDA's Robert Temple during a recent workshop said there is "tremendous […]
Germany Agency Calls for Drug Development, Approval Reforms
The Institute for Quality and Efficiency in Health Care (IQWiG) is calling for international reforms to the drug development and approval cycles, FiercePharma reports. According to the report, the agency found that only 25 percent (54) of 216 approvals between 2011 and 2017 delivered major health […]
FDA’s Woodcock Talks Big Changes
Janet Woodcock, chief of the FDA's Center for Drug Evaluation and Research, recently discussed a host of key changes being made at the agency, according to an Endpoint News report. According to the report, Woodcock touched on changes to clinical trial designs and other aspects of drug […]
Trump Scraps Rebate Proposal
The Trump administration this week scrapped a key proposal that would have eliminated pharma-PBM rebates in Medicare, an effort aimed at reducing prescription drug prices, the Washington Post reports. According to the report, the the administration's decision to pull the plug on the proposal […]
More on ACA Hearing
A federal court heard arguments on the constitutionality of the Affordable Care Act health care mandate this week. To read about the 90-minute hearing, click here to read Fierce Healthcare's report. […]
Uncertainty Abound on ACA Mandate
The fate of the Affordable Care Act's health care mandate remains uncertain after a hearing Tuesday in which a panel of federal appeals court judges listened to oral arguments on the rule's constitutionality, the New York Times reports. It remains unclear, according to the report, what scrapping […]
Judge Blocks Trump’s Rule on Drug Prices in DTC Ads
A federal judge this week blocked the Trump administration's rule requiring pharmaceutical companies include a drug's list price in television ads, STAT reports. The decision argues Health and Human Services (HHS) had insufficient authority to force drugmakers to disclose list prices in TV ads, and […]
Hearing Today on ACA’s Constitutionality
A hearing today, July 9, at the 5th Circuit Court of Appeals in New Orleans could decide whether a federal judge's ruling that the Affordable Care Act is unconstitutional will stick. According to a Kaiser Health News report, the hearing is poised for the Supreme Court, and could play a key role in […]
Report: Widespread Inaccuracies in Medicare Advantage Plan Directories
A Centers for Medicare and Medicaid Services (CMS) audit and other researchers have found widespread inaccuracies in Medicare Advantage plan directories, according to a recent article by Austin Frakt published on the New York Times. According to the article, CMS, which oversees the […]
Trump Vows Executive Action on Drug Prices
As part of his plan to reduce drug prices, President Donald Trump last week announced his administration would issue an executive order that he said would cap the U.S.'s payments for drugs, STAT reports. "Why should other nations — like Canada — but why should other nations pay much less than us?" […]
Lawmakers Working Toward Bipartisan Solution to Health Costs
U.S. policymakers are reaching across the aisle in an effort to come to a bipartisan solution to lower health care costs, the Associated Press reports. Legislators are looking at a number of issues, including surprise medical bills, high drug prices and prescription copays for Medicare […]
Drugmakers Push Back Against Rule on Drug Prices in TV Ads
Merck, Eli Lilly and Amgen are pushing back against the Trump administration's rule requiring drugmakers include a drug's list price in television ads, Westlaw Practitioners Insights reports. The companies on Monday, July 1, filed a brief in federal court, according to the report, arguing that the […]
FDA to Require Sponsors to Submit Promotional Materials Electronically for Accelerated Programs
The Food and Drug Administration (FDA) in a final guidance says sponsors who submit drugs through accelerated programs must submit promotional materials in advance beginning in 2021, FDAnews reports. The guidance was issued Friday, June 28. To read more on FDAnews, click here. […]
Measure Creating Drug Pricing Board Becomes Law
A measure passed by state legislators in Maryland to create the nation's first drug affordability board became law today, July 1, according to a STAT report. The Prescription Drug Affordability Board will have the power to cap how much state and local governments pay for prescription drugs. […]
Looking at Germany’s Model for Drug Prices
With stakeholders sparring over whether allowing Medicare to negotiate directly with manufacturers is a way to wrangle rising drug prices, Germany's model could lend some insight into the benefits of direct negotiations, the author of a recent column published on STAT writes. Germany, University of […]
White House: Order Mandates Health Care Price Transparency
The White House says a new executive order signed by President Donald Trump will mandate increased transparency on treatment costs and price negotiations, HealthPayerIntelligence reports. The executive order was issued June 24. According to the report, payers, providers and self-insured health […]
Gottlieb Joins Pfizer Board After Exiting Government
Former Food and Drug Administration commissioner Scott Gottlieb this week was appointed to Pfizer's board of directors, two months after exiting his government post, pharmaphorum reports. According to the report, Gottlieb was appointed to Pfizer's Regulatory and Compliance Committee and the Science […]
Newly-Released Emails Shed More Light into Alleged Price-Fixing Scheme
A new batch of emails made public by the Connecticut Attorney General's office this week revealed how a lawyer for Heritage Pharmaceuticals attempted to coordinate with other drugmakers for a response to a Congressional inquiry, The Middletown Press reports. "In early October 2014, Heritage […]
Blog: Use RWD, Not an International Pricing Index
While the White House's efforts to trim prices for drugs covered by Medicare through an international pricing index is a "laudable goal," using real-world data is the better solution, the author of a recent blog post on the American Enterprise Institute (AEI) writes. Kirsten Axelsen, visiting […]
Think Tank Points to High Health Costs, Consolidation
The Center for American Progress (CAP), a left-leaning think tank, found acute care hospitals in 2016 posted the highest total margins in more than a decade at 8 percent, Healthcare Dive reports. CAP's report also found that rising hospital prices "continue to drive up premiums and cost-sharing for […]
Analysis Suggests Ohio’s Efforts to Curb PBMs ‘Mostly Futile’
A recent analysis conducted by The Columbus Dispatch suggests that Ohio will continue to struggle with pharmacy benefit managers so long as they remain so deeply rooted in drug pricing for the state's Medicaid system. The analysis looked at 400,000-plus prescriptions from roughly 36 pharmacies in […]
HHS Submits Proposal for International Pricing Index to White House
The Department of Health and Human Services (HHS) last week submitted to the White House its proposal for an international pricing index, The Hill reports. Officials say the price benchmarking tool could help cut the prices of some drugs covered by Medicare. "We're going to end that foreign […]
Article Looks at Big Pharma’s Lawsuit on TV Ad Rule
A recent article by American Council on Science and Health Senior Medical Fellow Charles Dinerstein highlights a recent lawsuit filed be three pharmaceutical companies fighting the Trump administration's mandate which requires drugmakers to include a drug's list price in television ads. Amgen, […]
Article: Shift Focus on Drug Pricing Discussion
Policymakers and organizations should focus more on developing alternative payment models to broaden access to drugs without risking the funds necessary to fuel drug development, Forward Ventures Founding Managing Member Standish Fleming writes in a recent article on Forbes. "Drug development is […]
Connecticut Comptroller Touts New Deal with CVS Caremark
Connecticut State Comptroller Kevin Lembo says a new contract agreement with CVS Caremark "establishes one of the most innovative and transparent pharmacy benefits contracts in the nation." Lembo's office announced a deal had been reached on Wednesday, June 19. The arrangement, he says, is poised […]
FTC OKs UnitedHealth’s Acquisition of DaVita
UnitedHealth's $4.3 billion acquisition of DaVita Medical Group can move forward after the Federal Trade Commission gave the green light Wednesday, June 19, Healthcare Dive reports. The deal, which was announced in December 2017, is part of UnitedHealth and Optum's vertical integration […]
Can Germany’s Model for Prescription Drugs Work in the U.S.?
An international survey by The Commonwealth Fund found that only 7 percent of Germans reported issues concerning health care costs since 2018, according to a Los Angeles Times report, whereas one-third of Americans reported cost-related woes. "There is a lot we could learn," AARP's Leigh Purvis […]
States Eye Massachusetts’ Plan to Wrangle Drug Costs
States are keeping a close eye on Massachusetts as it attempts to wrangle prescription drug spending in its MassHealth program, The Meadville Tribune reports. According to the report, Massachusetts Gov. Charlie Baker proposed giving power to health officials to post a drug's value if it's found to […]
Drugmakers Suing Trump White House Over Ad Mandate
Drugmakers Amgen, Merck and Eli Lilly are suing the Trump administration over its recent rule requiring pharmaceutical companies to include a drug's list price in television ads, STAT reports. The Association of National Advertisers is also involved in the lawsuit, according to the report. Amgen […]
